Method and apparatus for coupling soft tissue to bone

ABSTRACT

A method for securing a suture to bone can include loading the suture in a distal opening of an inserter of an assembly. The suture can be coupled to soft tissue. The assembly can include the inserter, an anchor carried by the inserter, a distal tip and a driver each coupled to the inserter. A hole can be formed in the bone with the distal tip, and the distal opening and a portion of the suture can be positioned in the hole. The driver can be actuated to allow movement relative to the inserter and can be advanced in a first direction to drive the anchor about the inserter into the hole to secure the distal tip, anchor and suture to the bone with an absence of a knot. The driver can be moved in a second direction to remove the inserter from the distal tip, anchor and suture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/832,344, filed on Jun. 7, 2013 and is a continuation of U.S. patentapplication Ser. No. 14/019,646 (now issued as U.S. Pat. No. 9,936,940).The disclosure of the above applications are incorporated herein byreference.

FIELD

The present disclosure relates generally to a method and apparatus forcoupling a suture and/or soft tissue to bone.

BACKGROUND

The background description provided herein is for the purpose ofgenerally presenting the context of the disclosure. Work of thepresently named inventors, to the extent it is described in thisbackground section, as well as aspects of the description that may nototherwise qualify as prior art at the time of filing, are neitherexpressly nor impliedly admitted as prior art against the presentdisclosure.

Surgical or medical procedures are often performed on a body, forexample, a human body or anatomy, to repair or replace various portionsthereof. For example, the soft tissues of the body may need to bereattached to bones due to trauma, overuse, surgical intervention, ordisease. Soft tissue can be reattached to bone using devices such asscrews, staples, and various types of suture anchors. One means to fixthe soft tissue to the selected area is to provide a suture through aselected portion of the soft tissue and fix the other end of the sutureto a selected area on the bone using a suture anchor and a preformedhole in the bone, which can require various different instruments andtying a knot to secure the suture to the anchor. Accordingly, there is aneed for improvement in the relevant art.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

In one form, a method for securing a suture to bone is provided inaccordance with various aspects of the present disclosure. The methodcan include loading the suture in a distal opening of an inserter of aflexible member securing assembly. The assembly can include theinserter, a suture anchor carried by the inserter, a distal tipremovably coupled to a distal end of the inserter and a driver coupledto the inserter. The suture can be positioned between the suture anchorand the distal tip in an absence of extending through the suture anchorand the distal tip. An outer surface of the bone can be pierced with thedistal tip. The inserter can be advanced relative to the bone to form apilot hole in the bone and position a distal end of the suture anchorrelative to the outer surface of the bone. The distal opening, thedistal tip and a portion of the suture loaded therein can be positionedin the pilot hole. The driver can be actuated to allow movement of thedriver relative to the inserter. The driver can be advanced relative tothe inserter in a first direction to drive the suture anchor about theinserter into the pilot hole and compress a portion of the suturebetween the distal end of the suture anchor and the distal tip to securethe suture anchor and the suture to the bone with an absence of a knot.The driver can be moved in a second opposite direction to remove theinserter from the pilot hole and the distal tip, suture anchor andsuture.

In another form, a method for securing soft tissue to bone is providedin accordance with various aspects of the present disclosure. The methodcan include loading a suture in a distal opening of an inserter of aflexible member securing assembly. The suture can be coupled to softtissue and the assembly can include the inserter, a suture anchorcarried by the inserter, a distal tip removably coupled to a distal endof the inserter, and a driver coupled to the inserter. The sutureanchor, inserter and driver can be concentric about a centrallongitudinal axis of the flexible member securing assembly and thesuture can be positioned between the suture anchor and distal tip in anabsence of extending through the suture anchor and the distal tip. Theinserter can be advanced into a hole in the bone using the driver toposition a distal end of the suture anchor relative to an outer surfaceof the bone. The distal opening, distal tip and a portion of the sutureloaded therein can be positioned in the hole. The suture can betensioned relative to the distal opening and the soft tissue. A lockmember associated with the driver can be actuated to allow movement ofthe driver relative to the inserter. The driver can be advanced relativeto the inserter in a first direction to drive the suture anchor aboutthe inserter into the hole and compress the suture between the distalend of the suture anchor and the distal tip and secure the suture anchorand the suture to the bone with an absence of a knot. The driver can bemoved in a second opposite direction to remove the inserter from thehole, the suture anchor and the suture.

In yet another form, a flexible member securing assembly for use insecuring a flexible member relative to bone is provided in accordancewith various aspects of the present disclosure. The assembly can includean inserter, a distal tip, a driver assembly and an anchor. The insertercan have a body extending along a longitudinal axis from a proximal endto a distal end. The driver assembly can include a handle and a drivemember coupled to the handle. The proximal end of the inserter can bepositioned in an internal bore of the drive member and handle. A lockarrangement can be associated with the driver assembly and can beconfigured to selectively lock the inserter to the driver assembly inone of a plurality of positions. The inserter can extend through aportion of the lock arrangement. The anchor can be slidably carried onthe inserter, and the inserter, driver assembly and anchor can beconcentric about the longitudinal axis. A distal opening can be formedin the inserter proximate the distal end and can be adapted to receive aflexible member and selectively retain the flexible member therein. Thedistal tip can be removably coupled to the distal end of the insertersuch that the flexible member can be adapted to be coupled to theinserter between the distal tip and the anchor in an absence ofextending through the distal tip and the anchor. The distal tip can beadapted to form a pilot hole in the bone via a force applied to thedriver assembly. The driver assembly can be adapted to insert the anchorinto the pilot hole about the inserter and into substantial engagementwith the distal tip to secure the anchor and flexible member to the bonewith an absence of a knot.

In some examples, actuating the driver can include actuating a lockarrangement to disengage a lock member from engagement with the inserterat a first position to allow axial movement of the driver relative tothe inserter, where the inserter can be positioned in an internal boreof the driver. The driver can be advanced relative to the inserter inthe first direction and rotated relative to the inserter to drive thesuture anchor about the inserter into the pilot hole while the inserterremains positioned in the pilot hole. In various examples, the driverassembly can be configured to be advanced relative to the inserter toinsert the anchor into the bone to a predetermined depth at which thelock member can automatically engage the inserter at a second positionaxially spaced apart from the first position to fix the driver assemblyto the inserter.

In various examples, the suture can be compressed between an outersurface of the suture anchor and a wall of the pilot hole. In accordancewith various aspects, moving the driver in the second opposite directioncan automatically remove the distal opening from the suture. In certainexamples, the suture can include a self-locking adjustable sutureconstruct.

According to various examples, the removably coupled distal tip cancapture the suture between the distal tip and the distal end of thesuture anchor. In some examples, the suture can be positioned betweenfirst and second spaced apart projections axially extending from aproximal end of the distal tip.

Further areas of applicability of the present disclosure will becomeapparent from the description provided hereinafter. The description andspecific examples in this summary are intended for purposes ofillustration only and are not intended to limit the scope of the presentdisclosure.

DRAWINGS

The present teachings will become more fully understood from thedetailed description, the appended claims and the following drawings.The drawings are for illustrative purposes only and are not intended tolimit the scope of the present disclosure.

FIG. 1 is a perspective view of an exemplary flexible member securingassembly in accordance with various aspects of the present disclosure;

FIG. 2 is an enlarged view of a distal end area of the exemplaryflexible member securing assembly of FIG. 1 according to various aspectsof the present disclosure;

FIG. 3 is a partial sectional view of the distal end area of FIG. 2according to various aspects of the present disclosure;

FIG. 4 is a partial sectional view of a proximal handle of the exemplaryflexible member securing assembly according to various aspects of thepresent disclosure;

FIG. 5 is a view of an alternative exemplary inserter and rigid body foruse with the exemplary flexible member securing assembly according tovarious aspects of the present disclosure;

FIG. 6 is a view of the inserter of FIG. 5 with a distal tip in aflexible member receiving configuration according to various aspects ofthe present disclosure;

FIG. 6A is a view of the inserter of FIG. 5 with an exemplaryalternative rigid body according to various aspects of the presentdisclosure;

FIGS. 7-10 depict an exemplary method of using a flexible membersecuring assembly according to various aspects of the presentdisclosure;

FIGS. 11-13 depict an alternative exemplary inserter and rigid body andan exemplary method of using the same according to various aspects ofthe present disclosure;

FIG. 14 depicts an exemplary flexible member construct according tovarious aspects of the present disclosure;

FIG. 15 depicts an exemplary method of using the exemplary flexiblemember construct along with an exemplary rigid body according to variousaspects of the present disclosure; and

FIGS. 16 and 17 are views of an exemplary alternative rigid bodyassembly and associated inserter assembly according to various aspectsof the present disclosure.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present disclosure, its application, or uses.Although the following description is related generally to methods andapparatus for securing a flexible member to bone, it should beappreciated that the methods and apparatus discussed herein can beapplicable to various bones and/or joints of the anatomy and can beutilized with various flexible members and rigid bodies or anchors.

Exemplary embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, systems and/or methods, to provide athorough understanding of exemplary embodiments of the presentdisclosure. It will be apparent to those skilled in the art thatspecific details need not be employed, that exemplary embodiments may beembodied in many different forms and that neither should be construed tolimit the scope of the disclosure. In some exemplary embodiments,well-known processes, well-known device structures, and well-knowntechnologies are not described in detail.

The present teachings provide a flexible member securing assembly and amethod for using the same to secure a flexible member to bone with arigid body and without using a knot. In an exemplary aspect, theflexible member can be a suture and the rigid body can be an anchor. Inan exemplary aspect, the flexible member securing assembly can includean inserter, a driver or driver assembly and a rigid body movablycoupled to each other and provided preassembled in a kit. In anotherexemplary aspect, the inserter can form a pilot hole in bone forreceiving the rigid body while the rigid body and driver remain coupledto the inserter.

With initial reference to FIGS. 1-4, a flexible member securing assemblyis provided and generally identified at reference numeral 10. Theflexible member securing assembly 10 can include an inserter or centralpunch 20, a driver 30, a rigid body 40 and a handle 50. As discussedabove, the flexible member securing assembly 10 can, in certainembodiments, be provided in a preassembled configuration as generallyshown in FIG. 1.

The inserter 20 can include a proximal end 60 (FIG. 4) and a distal end64. The distal end 64 can include a conical tip 68 configured topenetrate bone to form a pilot hole or bore therein, as will bediscussed in greater detail below. In one exemplary implementation, theconical tip 68 can form the distal end 64. The inserter 20 can include adistal slot or eyelet 74, as generally shown in FIGS. 2-3. The distalslot 74 can include an opening 78 proximate the distal end 64 that isconfigured to receive one or more flexible members or sutures. In oneexemplary embodiment, the opening 78 can be adjacent the conical tip 68so as to place the sutures at a predetermined depth in the bone, as willbe discussed in greater detail below. With particular reference to FIG.2, the slot 74 can include one or more ridges or protrusions 82 and oneor more valleys or recesses 86 to aid in retaining one or more flexiblemembers therein. In the exemplary embodiment illustrated in FIG. 2, theprotrusion 82 and the recess 86 can be opposed from each other.

As can also be seen in FIG. 2, the inserter 20 can include a solid body90 extending from the proximal end 60 to the distal end 64. It should beappreciated, however, that the body 90 could also be formed in variousother configurations, including hollow or cannulated. In one exemplaryembodiment, the inserter can be formed as a rod or elongated cylinder.In another exemplary embodiment, the rod can include truncated sides 94extending along a longitudinal length of inserter 20, as also shown inFIG. 2. The inserter 20 can include a depth indication 98 positionednear the distal end 64 thereof. The depth indication 98 can correspondto a predetermined position that the inserter 20 can be driven into bonebefore implanting the rigid body 40. In one exemplary embodiment, thedepth indication 98 can be a mark or ring formed in the inserter 20. Itshould be appreciated, however, that the depth indication 98 can beformed in various different configurations including with or withoutusing color as part of or the entire indication 98.

The rigid body 40 can be a suture anchor, a bone screw or other fixationdevice. The suture anchor 40 can include a body 104 having a proximalend 108, a distal end 112 and a throughbore 116, as generally shown inFIG. 3 with reference to FIG. 2. The suture anchor 40 can be formed ofany appropriate biocompatible material including polymers, co-polymers,such as polyetheretherketone (PEEK), metals, such as titanium, andvarious alloys, formed from titanium, cobalt, chromium, etc. Thethroughbore 116 can include an internal width or diameter 120 configuredto be complimentary to an external diameter or width of inserter 20 suchthat the inserter can be slidably received through the throughbore 116.In one exemplary implementation, the internal diameter of thethroughbore 116 can be sized and shaped to provide a relatively tight orsnug fit so as to prevent any unintended movement of suture anchor 40relative to inserter 20.

The suture anchor 40 can include tissue or bone engaging features 124positioned on an exterior 130 (FIG. 2) thereof. In the exemplaryembodiment shown in FIGS. 1-4, the bone engaging features 124 caninclude threads, such as helical threads 128. It should be appreciated,however, that various other bone engaging features 124 may be utilized,such as ribs or protrusions. In one exemplary configuration, the sutureanchor 40 can include a suture retention feature 134 at the distal end112, as shown for example in FIG. 3. In this exemplary configuration,the suture retention feature 134 can be a recess or depression that canprevent suture strands from sliding around or off of the distal end 112.

The distal end 112 can also include a non-threaded portion 138, as shownin FIG. 3. It should be appreciated, however, that the threads 128 canalternatively extend along an entire length of the body 104. Theproximal end 108 of body 104 can include a driver engaging feature 144configured to receive a corresponding feature on a distal end of thedriver 30. In the exemplary embodiment shown, the driver engagingfeature 144 can include an internal hexagon pattern configured toreceive an external hexagon pattern formed on the distal end of driver30, as will be discussed in greater detail below. It should beappreciated, however, that the driver engaging feature 144 can includeany male feature or female bore shape configured to receive the driver30 and prevent relative rotational movement between the driver 30 andthe suture anchor 40.

The driver 30 and handle 50 can be provided as separate components thatcan be coupled together by a user, or can be provided as an integraldriver assembly 148. Thus, while individual components of the driverassembly 148 (i.e., driver 30 and handle 50) will be discussed below, itshould be appreciated that such components can be provided in theintegrated form of driver assembly 148. In one exemplary implementation,the inserter 20, driver 30, handle 50 and suture anchor 40, whenassembled together, can be concentric with each other about a centrallongitudinal axis 150 as shown for example in FIGS. 1 and 3.

The driver 30 can include a cannulated body 154 extending from aproximal end 158 (FIG. 4) to a distal end 162, and can define athroughbore 166 extending therebetween. The distal end 162 can include amale suture anchor engaging feature 170 corresponding to the femaleengaging feature 144 of the suture anchor 40. In the exemplaryconfiguration illustrated in FIGS. 1-4, the male engaging feature 170can be a hexagon head sized and shaped to be received in the proximalend 108 of the suture anchor 40 and transmit rotational torque thereto,as will be discussed in greater detail below. The driver 30 can bereceived over the proximal end 60 of the inserter 20 and positionedthereon in engagement with the suture anchor 40, as generally shown inFIG. 1 with reference to FIGS. 3 and 4.

The proximal end 158 of the driver 30 can be fixed to the handle 50, asgenerally shown in FIG. 4. The handle 50 can be used to grasp andmanipulate (e.g., cause movement of) the flexible member securingassembly 10. The handle 50 can include a proximal end 178, a distal end182 (FIG. 1), a locking arrangement 186, and can define a throughbore190. The handle 50 can be fixedly coupled to the driver 30, as discussedabove and shown in FIG. 4. The handle 50 and driver 30 (driver assembly148) can be slidably positioned over the proximal end 60 of the inserter20 such that a proximal portion 194 of the inserter 20 adjacent theproximal end 60 thereof extends beyond the proximal end of driver 30 andat least partially into the throughbore 190, as also shown in FIG. 4.

The locking arrangement 186 can include an actuator 196, a lock member198, and an optional biasing member 202. The locking arrangement 186 canbe configured to selectively engage the handle 50 (and thus the driver30) to the inserter 20 in one of a plurality of positions. In oneexemplary embodiment, the locking arrangement 186 can be configured toaxially fix the driver assembly 148 to the inserter 20 in a firstposition 204 such that a force applied to the handle 50 causes movementof the driver assembly 148 and inserter 20 as a combined unit. Uponactuation of the locking arrangement 186 to release the handle 50 fromengagement with the inserter 20 at the first position 204, the driverassembly 148 can slide axially relative to the inserter 20 to move thesuture anchor 40 relative to the inserter 20, as will be discussed ingreater detail below. In one exemplary embodiment, the lockingarrangement 186 can be configured to automatically reengage the inserter20 at a second position 208 to again axially fix the driver assembly 148to the inserter 20.

In the exemplary embodiment shown in FIG. 4, the actuator 196 caninclude a button or other depressible member 214 positioned in a cavity218 formed on a first side 222 of handle 50. The button 214 can includea shaft or projection 226 extending therefrom and toward a secondopposed side 230 of handle 50. The projection 226 can include a cut-outor clearance 234 configured to allow the inserter 20 to move relativethereto, as shown in FIG. 4. The projection 226 can be coupled to thelock member 198, which can be selectively coupled to a first retentionfeature or depression 238 in inserter 20 that forms the first position204. Depression of the button 214 into cavity 218 can move the lockmember 198 out of first depression 238 thereby selectively disengaginglock member 198 from inserter 20. It should be appreciated that whilethe flexible member securing assembly 10 has been discussed as includingthe locking arrangement 186, the securing assembly 10 can includevarious different locking arrangements, such as a key slot arrangement,that are configured to selectively lock the driver assembly 148 to theinserter 20.

As discussed above, a biasing member, such as a spring or other elasticmember 202, can bias the button 214 to a non-depressed position which,in turn, can bias the lock member 198 into engagement with inserter 20.Upon disengagement of the lock member 198 from the first position 204 ofinserter 20 in the manner discussed above, the driver assembly 148 canbe axially advanced relative to the inserter 20 in a direction towardthe distal end 64 of inserter 20. The button 214 can then be releasedthereby providing for the biasing member 202 to bias the lock member 198into sliding engagement with the body 90 of inserter 20. While the lockmember 198 is slidably engaged with the body 90 of inserter 20, thehandle 50 can be rotationally and/or axially advanced relative to theinserter 20 until the lock member 198 aligns with a second retentionfeature or depression 242 that forms the second position 208. Upon suchalignment, the biasing member 202 can automatically move the lock member198 into engagement with the second depression 242 thereby againselectively fixing the handle 50 and driver 30 (driver assembly 148) tothe inserter 20.

With additional reference to FIGS. 5 and 6 and continuing reference toFIGS. 1-4, an alternative exemplary inserter 20′ is shown having analternative distal end 64′. The alternative inserter 20′ can be utilizedwith assembly 10 in place of inserter 20 or with a different assembly.In the exemplary embodiment illustrated, the alternative distal end 64′can include a movable eyelet configuration 250 for selectively receivingone or more flexible members, such as sutures, and for forming the pilotbore in the bone. The moveable eyelet configuration 250 can include oneor more movable jaws 254 that can be selectively positioned in an openposition 258 and a closed position 262. The closed position 262 (FIG. 5)can form an enclosed distal eyelet 266, as well as a conical distal tip68′ for use in forming the pilot bore in the bone.

With particular reference to FIG. 6, one or more of the jaws 254 can bemoved to the open position 258 to thereby create an opening 270 forloading one or more sutures 274 in the distal eyelet 266. The eyelet 266can be sized and shaped such that when the movable jaws 254 are in theclosed position 262, the one or more sutures 274 can slide relative todistal eyelet 266. The one or more movable jaws 254 can provide forarthroscopic loading of the one or more sutures 274 in the distal eyelet266. The conical distal tip 68′ can be used to pierce the bone and forma bore therein, as will be discussed below in greater detail.

With continuing reference to FIGS. 5-6A, an alternative suture anchor40′ is shown slidably coupled to inserter 20′ in the same manner asdiscussed above for suture anchor 40 and inserter 20. Suture anchor 40′can be similar to suture anchor 40 such that only differences will bediscussed below in detail. Suture anchor 40′ can include bone engagingfeatures 124 in the form of external ribs or protrusions 284. Sutureanchor 40′ can also include one or more openings or fenestrations 288defined by the cannulated body 104, as shown for example in FIG. 6A. Inone exemplary configuration, suture anchor 40′ can include a pluralityof fenestrations 288 extending through body 104 from the exterior 130 tothe throughbore 116. The fenestrations 288 can be provided in variousdimensions and/or geometries and can promote healing and in-growth ofbone. The fenestrations 288 can also decrease a mass of the sutureanchor 40′, which can also serve to promote healing. It should beappreciated that while fenestrations 288 are shown in association withsuture anchor 40′ in FIG. 6A, the fenestrations 288 can be provided withany of the various suture anchors discussed herein.

Suture anchor 40′ can be axially driven or punched into the bone bydriver 30 as opposed to being threaded into the bone. In this regard,the distal end 162 of driver 30 can include the same male engagingfeature as used with suture anchor 40, or can include an alternativemale engaging feature as rotational torque is not required for sutureanchor 40′. Likewise, the proximal end of suture anchor 40′ can includethe same female engaging feature 144 as suture anchor 40, or analternative engaging feature corresponding to the alternative engagingfeature of driver 30. In one exemplary embodiment, the alternative maleengaging feature can be a reduced diameter portion forming an externalshoulder, and the alternative female engaging feature can be an annularrecess forming an internal shoulder. It should be appreciated that thesuture anchors 40, 40′ can be used with either inserter configuration20, 20′ discussed herein.

With additional reference to FIGS. 7-10 and continuing reference toFIGS. 1-6, an exemplary method for securing soft tissue to bone withflexible member securing assembly 10 will now be discussed. It should beappreciated that while the discussion will continue with reference toflexible member securing assembly 10 having inserter 20 and sutureanchor 40, the alternative suture anchor 40′ and/or alternative inserter20′ could also be utilized to secure the sutures and soft tissue to bonewithout a knot.

With particular reference to FIG. 7, one or more sutures 274 coupled tosoft tissue 278 can be loaded onto inserter 20 of the flexible membersecuring assembly 10. It should be appreciated that the sutures 274 canbe loaded onto the inserter 20 in an assembled configuration, as shownin FIG. 1, or onto an individual inserter 20 which can then be slidablycoupled to the driver assembly 148. The discussion will continue,however, with reference to use of the assembly 10 in the preassembledconfiguration.

In the exemplary configuration illustrated, two looped suture strands274 can be positioned in slot 74 of inserter 20 such that free ends 286extend beyond slot 74 a distance greater than a longitudinal length ofanchor 40. It should be appreciated, however, that the free ends 286could extend from slot 74 more or less than discussed above. It shouldalso be appreciated that various other suture configurations could becoupled to slot 74 and/or the soft tissue 278, including variousknotless self-locking adjustable suture constructs, an example of whichwill be discussed herein.

With the desired suture strands loaded onto inserter 20, the distal tip68 can be positioned at a desired suture retention location of a bone290, as shown for example in FIG. 7. The driver 30 can be selectivelyfixed to the inserter 20 at the first position 204, as discussed aboveand shown in FIG. 3. A force can then be applied to the flexible membersecuring assembly 10, such as an axial force in the direction of arrowA, to punch or drive the distal tip 68 of inserter 20 into bone 290, asshown for example in FIG. 8. Once the distal tip 68 pierces an outersurface 294 of the bone 290, the securing assembly 10 can be furtherdriven in the direction of arrow A to form a pilot hole 298 in bone 290for receipt of suture anchor 40.

In the exemplary configuration illustrated in the various figures, theaxial force can be applied to the proximal end of handle 50 of driverassembly 148, which can be selectively fixed to inserter 20. Theinserter 20 can be driven via driver assembly 148 until the depthindication 98 is roughly in line with the outer surface 294 of bone 290,as also shown in FIG. 8. When the inserter 20 is in this position, theslot or eyelet 74 can be positioned at a predetermined depth below theouter surface 294 of the bone 290 such that the opening of the eyelet 74is below a depth for driving the suture anchor 40 below the outersurface 294 of the bone 290. First and second portions 304 of the suturestrands 274 can extend from the eyelet 74 out of the formed pilot hole298, as also shown in FIG. 8. It should be appreciated, however, thatthe hole 298 could alternatively be pre-drilled.

As discussed above, the suture strands 274 can be slidably positioned ineyelet 74 such that the free ends 286 can be tensioned to draw the softtissue 278 to a desired position relative to the formed pilot hole 298.In the example illustrated, the free ends 286 can be tensioned to drawthe soft tissue 278 to a position adjacent an opening 308 of pilot hole298 while the distal tip 68 of inserter 20 is positioned in pilot hole298. With the sutures 274 tensioned as discussed above, an axial forcecan again be applied to handle 50 to punch the distal end 112 of sutureanchor 40 slightly into bone 290. In one exemplary configuration, thenon-threaded portion 138 of suture anchor 40 can be driven into bone 290via an axial force imparted onto handle 50.

The actuator button 214 of handle 50 can then be depressed in the mannerdiscussed above to release driver assembly 148 from being selectivelyfixedly coupled to inserter 20. A rotational force can be applied tohandle 50 to rotate driver 30 about inserter 20 and thread suture anchor40 into bone 290. In other words, inserter 20 can remain stationary orpositioned in bone 290 while suture anchor 40 is threaded into pilothole 298 to a predetermined depth. In this regard, inserter 20 can serveas a guide for threading suture anchor 40 into bone 290. It should beappreciated, however, that the actuator button 214 can be depressedafter tensioning the sutures 274 and before applying the axial force tothe handle 50 to punch the distal end 112 of suture anchor 40 slightlyinto bone 290.

Suture anchor 40 can include a larger outer diameter than an innerdiameter of pilot hole 298 such that a threaded interference fit 314 iscreated between the bone 290 and suture anchor 40 as the anchor isthreaded into pilot hole 298 about inserter 20. The first and secondsuture portions 304 can be positioned between an outer surface 318 ofthe suture anchor 40 and an inner wall 320 of the pilot hole 298 suchthat the threaded interference fit 314 secures the suture strands 274and thus the soft tissue 278 coupled thereto to bone 290 withoutrequiring a knot or additional suture tying device. In one exemplaryimplementation, the suture portions 304 can be compressed between theouter surface 318 of suture anchor 40 and the inner wall 320 of pilothole 298.

As discussed above, the suture anchor 40 can be threaded into pilot hole298 of bone 290 to a predetermined depth to lock the sutures 274 to bone290. In one exemplary configuration, the predetermined depth can be adepth at which the proximal end 108 of suture anchor 40 is flush orsubstantially flush with the outer surface 294 of bone 290 or below theouter surface 294 of bone 290. In an exemplary configuration, thepredetermined depth can be coordinated with the second position 208 ofinserter 20. In this configuration, when the predetermined depth isreached, the lock member 198 can align with the second position 208.Upon such alignment, the biasing member 202 can automatically urge thelock member 198 into engagement with the second depression 242 therebypreventing further advancement of the driver 30 (and thus suture anchor40) relative to inserter 20.

Once suture anchor is threaded to the predetermined depth, such as inthe manner discussed above, the inserter 20, driver 30 and handle 50 canbe removed simultaneously. In particular, since the driver assembly 148can be selectively fixed to the inserter 20 at the second position 208,the handle 50 can be moved in a direction opposite of arrow A to slidethe inserter 20 and driver assembly 148 out of pilot hole 298 andrelative to suture anchor 40, as shown for example in FIG. 10. A loopedend 324 of the suture strands 274 can slide out of slot 74 via opening78 as the inserter 20 and driver assembly 148 are removed simultaneouslyas a unit. It should be appreciated that while flexible member securingassembly 10 is discussed above in connection with forming pilot hole298, the assembly could also be used with a preformed hole 298.

Turning now to FIGS. 11-13, an alternative flexible member securingassembly 10′ will now be discussed. Flexible member securing assembly10′ can be similar to flexible member securing assembly 10 such thatonly differences will be discussed in detail and like reference numeralscan refer to like or similar components and/or features. The flexiblemember securing assembly 10′ can include an inserter 20″ having analternative distal end 64″. The alternative distal end 64″ can include aforked end 400 having first and second spaced apart members 404 forminga channel 408 terminating in or forming a distal eyelet 412. An anchorbody in the form of a conical tip 416 can be removably secured to thedistal end 64″, which can form a selective closure of eyelet 412. In oneexemplary configuration, the first and second members 404 can bereceived in correspondingly sized and shaped bores 422 in conical tip416, as shown for example in FIG. 11. The bores 422 can, in oneexemplary configuration, be sized and shaped to create a slightinterference fit with first and second members 404 to releasably retainconical tip 416 on inserter 20″.

The flexible member securing assembly 10′ can be provided in apreassembled configuration and as part of a kit, similar to assembly 10.In this regard, the assembly 10′ can include a suture anchor 40″, apunch or inserter assembly 428 that includes inserter 20″ with conicaltip 416 preassembled thereto, the driver assembly 148, and a suturepasser, such as a Nitinol kite 432, prepositioned through distal eyelet412.

The suture anchor 40″ can be any suitable suture anchor having boneengaging external features 124 and a distal end configured to mate witha proximal end 438 of conical tip 416. In the exemplary configurationillustrated, suture anchor 40″ can be similar to suture anchor 40without the non-threaded portion 138, as shown for example in FIG. 11.

In operation, one or more suture strands 274 can be positioned through acapture loop 442 of suture passer 432, which can be coupled to theflexible member securing assembly 10′. The suture passer 432 can then beused to pull a portion of the suture strands 274 through distal eyelet412 such that, for example, the free ends are pulled through distaleyelet 412, as shown for example in FIG. 13 with reference to FIG. 12.

The flexible member securing assembly 10′ can be positioned at a desiredbone location for securing suture anchor 40″ in a similar manner asdiscussed above for assembly 10. An axial force can be applied to thedriver assembly 148, such as at the proximal end thereof, to drive thedistal end of inserter assembly 428 into the bone 290. In particular, inthe exemplary embodiment illustrated, the distal eyelet 412 with theloaded suture strands 274 and the conical tip 416 can be punched intothe bone 290 to form a bone hole 298′. Similar to assembly 10 discussedabove, first and second portions 304 of the suture strands 274 canextend from the distal eyelet 412 out of the bone hole 298′.

Once the punch assembly 428 is inserted into the bone 290 to apredetermined depth, such as a depth sufficient to place the proximalend 108 of suture anchor 40″ flush with or below the outer surface 294of bone 290, the suture anchor 40″ can be threaded into the bone 290about inserter 20″. In one exemplary embodiment, the driver assembly 148can be used to thread suture anchor 40″ into bone 290 in a similarmanner as discussed above for suture anchor 40.

With additional reference to FIG. 13, the suture anchor 40″ can bethreaded into bone 290 until a distal end 112′ engages the proximal end438 of conical tip 416. With this action, the first and second portions304 of suture strands 274 can be compressed between the outer surface318 of suture anchor 40″ and an inner wall 320′ of formed bone hole298′, as can be seen in FIG. 13. In one exemplary configuration, thelooped end 324 of suture strands 274 can be engaged by the distal end112′ of suture anchor 40″ as the anchor is being inserted toward conicaltip 416. This action can automatically remove the looped ends 324 fromthe distal eyelet 412 of inserter 20″ and place the looped ends 324 inengagement with the proximal end 438 of conical tip 416. Depending onthe insertion depth of the suture anchor 40″, the looped ends 324 can becompressed between the distal end 112′ of anchor 40″ and the proximalend 438 of conical tip 416. It should be appreciated that, in certainembodiments, a portion of the looped end 324 may remain in the distaleyelet 412 and/or channel 408 until the inserter 20″ is removed frombone 290, as will be discussed below.

In the exemplary configuration shown in FIG. 13, conical tip 416 caninclude two spaced apart projections 446 extending axially from theproximal end 438. In this configuration, the looped ends 324 and/oranother portion of the suture strands 274 can be positioned between theprojections 446 to aid in preventing the suture strands 274 from slidingaround the conical tip 416. Once the suture anchor 40″ is inserted tothe appropriate depth, such as the proximal end thereof being flush withor substantially flush with or below the outer surface 294 of bone 290,the inserter 20″ and driver assembly 148 can be simultaneously removedfrom bone 290. As can be seen in FIG. 13, the suture anchor 40″ andconical tip 416 can remain implanted in bone 290 thereby securing thesuture strands 274 to bone 290 without requiring a knot.

Turning now to FIGS. 14-15, an alternative suture configuration isprovided and, in one exemplary implementation, can be used with thevarious flexible member securing assemblies discussed herein. The sutureconfiguration can be in the form of a knotless, adjustable self-lockingsuture construct 450 shown in FIG. 14. As will be discussed below, freeends of suture construct 450 can be tensioned to reduce a size of theadjustable loops and can automatically maintain the reduced size withoutrequiring a knot. Suture construct 450 can be used, for example, tocompress a fractured or sectioned bone, to couple and/or tensionportions of the anatomy, and/or to secure soft tissue to bone.

As shown in FIG. 14, suture construct 450 can be formed from suture 274which, in this exemplary implementation, can be a hollow or braided ormultiple-filament braided suture having a hollow core. In variousaspects, the suture 274 can define a substantially tubular hollow shape.Suture construct 450 can be formed to include a double loopconfiguration having two loops that each traverse a path from one end ofa passage portion to the other end thereof, as will be discussed below.Suture construct 450 can include a body 454 that defines a longitudinalpassage portion 458 therein between first and second ends 462, 466. Thepassage portion 458 can define a pair of apertures 470, 474 at opposedends thereof.

Suture construct 450 can be formed by passing first end 462 throughaperture 474, through passage portion 458 and out aperture 470. Thesecond end 466 can be passed through aperture 470, through the passageportion 458 and out the aperture 474. In various aspects, the first andsecond apertures 470, 474 can be formed during the braiding process asloose portions between pairs of fibers defining the suture 274. Passingends 462, 466 through the apertures 470, 474 can form adjustable loops478, 478′. The adjustable loops 478, 478′ can define mount or summitportions 482, 482′ of the suture construct 450 and can be disposedgenerally opposite from the passage portion 458.

The longitudinal and parallel placement of the first and second ends462, 466 of suture 274 within the passage portion 458 resists thereverse relative movement of first and second portions 488, 492 of thesuture construct 450 once it is tightened. The tensioning of the ends462, 466 can cause relative translation of the portions 488, 492relative to passage portion 458. Upon applying tension to the first andsecond ends 462, 466, the loops 478, 478′ can be reduced to a desiredsize or placed in a desired tension. Tension in the loops 478, 478′ cancause the body of suture 274 defining the passage portion 458 to beplaced in tension and therefore cause passage portion 458 to constrictabout the portions 488, 492. This constriction can cause the adjustablesuture construct 450 to “automatically” lock in a reduced size orsmaller diameter configuration under tension without requiring a knot.

With additional reference to FIG. 15 and reference back to FIGS. 1-10,suture construct 450 is shown in an exemplary procedure for securingsoft tissue 278 to bone 290. Suture construct 450 can be used in asimilar procedure as discussed above for flexible member securingassembly 10. In one exemplary procedure, the summit portions 482, 482′can be coupled to slot 74 of inserter 20 in a similar manner asdiscussed above for suture strands 274. It should be appreciated thatwhile the discussion will continue with reference to flexible membersecuring assembly 10 and inserter 20, the suture construct 450 and thisprocedure could also be implemented with the various other insertersand/or securing assemblies discussed herein.

With the summit portions 482, 482′ coupled to inserter 20, the sutureanchor 40 can be implanted in the same or a similar manner as discussedabove in FIGS. 7-10, where the passage portion 458 and free ends 462,466 can extend from hole 298. As can be seen in FIG. 15, the summitportions 482, 482′ can be positioned adjacent to or engage the distalend 112 of suture anchor 40 and portions 498 extending therefrom can becompressed between anchor 40 and bone 290. Soft tissue 278 can bepositioned under passage portion 458 so as to be between passage portion458 and the outer surface 294 of bone 290. In other words, passageportion 458 and portions 502 of suture construct 450 extending from hole298 can encircle soft tissue 278 relative to bone 290. The free ends462, 466 of suture construct 450 can be tensioned to reduce a size ofloops 478, 478′ to secure soft tissue 278 to bone 290 under tension andmaintain such tension without use of a knot. In one exemplaryimplementation, the free ends 462, 466 can be tensioned after drivinginserter 20 into bone 290 to the predetermined depth with summitportions 482, 482′ coupled thereto and before implanting suture anchor40.

Turning now to FIGS. 16-17, another exemplary flexible member securingassembly 520 is shown in accordance with various aspects of the presentteachings. Flexible member securing assembly 520 can include an anchorassembly 524 and a driver assembly 528. Anchor assembly 524 can includea first or distal body member 532 and a second or proximal body member536.

First body member 532 can include lower portion 540 forming a distal end544 and an upper portion 548 extending from the lower portion 540 andforming a proximal end 552. The distal end 544 can be in the form of arounded or arcuate distal tip having a width or diameter larger than awidth or diameter of the upper portion 548 so as to form a shoulder 556.Upper portion 548 can include external threads and a blind channel 560having an opening at the proximal end 552. The second body member 536can be similar to or substantially similar to suture anchor 40″ with theinclusion of internal threads 564 and will not be discussed in greaterdetail herein.

The driver assembly 528 can include a first shaft member 570 and asecond shaft member 572. First shaft member 570 can be coaxiallyreceived in and slidable relative to second shaft member 572. Firstshaft member 570 can be sized and shaped to be received in throughbore116′ and can include a distal projection 574 sized and shaped to fit inchannel 560. Distal projection 574 can form a shoulder 578 with shaftmember 570, which can engage the proximal end 552 of upper portion 548,as shown in FIG. 17.

The second shaft member 572 can include a larger outer width or diameterthan first shaft member 570 and can include a male coupling featureconfigured to engage a female coupling feature in the proximal end ofsecond body member 536. In one exemplary configuration, the male andfemale coupling features include corresponding hexagonal patterns suchthat the second shaft member 572 can rotate second body member 536relative to first body member 532, as will be discussed in greaterdetail below.

In operation, the flexible member securing assembly 520 can be providedas a kit with the anchor assembly 524 preassembled to the driverassembly 528, as generally shown in FIG. 17 (except that the lowerportion 540 would be threadably engaged to the upper portion 548). Inthis configuration, the components of the flexible member securingassembly 520 can be concentric with each other.

Suture strands 274 or other flexible members can be positioned inchannel 560, as generally shown in FIG. 16. The first body member 532can be inserted into a formed hole in bone 290 and then the suturestrands 274 can be tensioned. The second shaft member 572 can be rotatedto thread the second body member 536 about the first body member 532 andinto the formed hole. The first shaft member 570 can prevent the firstbody member 532 from rotating. This action can thread second body member536 about the upper portion 548 of first body member 532 until a distalend of the second body member 536 engages the shoulder 556. Uponengagement of the second body member 536 with the shoulder 556, thesecond body member 536 can be threaded into the bone hole to apredetermined depth.

At this point of the procedure, the suture strands 274 can be pinched orcompressed between the distal end of the second body member 536 and theshoulder 556 of first body member 532, as well as between the outerthreaded surface of the second body member 536 and the wall of the bonehole thereby securing the suture strands 274 to bone without requiring aknot or additional securing device or procedure. The driver assembly 528can then be slidably removed from the implanted anchor assembly 524.

While one or more specific examples or aspects have been described andillustrated, it will be understood by those skilled in the art thatvarious changes may be made and equivalence may be substituted forelements thereof without departing from the scope of the presentteachings as defined in the claims. Furthermore, the mixing and matchingof features, elements and/or functions between various examples may beexpressly contemplated herein so that one skilled in the art wouldappreciate from the present teachings that features, elements and/orfunctions of one example may be incorporated into another example asappropriate, unless described otherwise above. Moreover, manymodifications may be made to adapt a particular situation or material tothe present teachings without departing from the essential scopethereof.

The terminology used herein is for the purpose of describing particularexample implementations only and is not intended to be limiting. As usedherein, the singular forms “a,” “an,” and “the” may be intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. The term “and/or” includes any and all combinations of one ormore of the associated listed items. The terms “comprises,”“comprising,” “including,” and “having,” are inclusive and thereforespecify the presence of stated features, integers, steps, operations,elements, and/or components, but do not preclude the presence oraddition of one or more other features, integers, steps, operations,elements, components, and/or groups thereof. The method steps,processes, and operations described herein are not to be construed asnecessarily requiring their performance in the particular orderdiscussed or illustrated, unless specifically identified as an order ofperformance. It is also to be understood that additional or alternativesteps may be employed.

What is claimed is:
 1. A flexible member securing system for use insecuring a flexible member relative to bone, the system comprising: aflexible member; an inserter having a body extending along alongitudinal axis from a proximal end to a distal end, wherein theinserter includes an eyelet therein configured to receive the flexiblemember and selectively retain the flexible member therein, wherein theinserter within the eyelet includes a protrusion on a first side withinthe eyelet and a recess spaced from the protrusion on a second sidewithin the eyelet, and wherein the protrusion extends laterally from anexterior side surface of the inserter at a lateral rim of the eyelet; adriver assembly including a handle and a drive member coupled to thehandle, the proximal end of the inserter configured to be received in aninternal bore of the drive member, wherein the driver assembly includesa lock arrangement configured to selectively lock the inserter to thedriver assembly in one of a plurality of positions when the inserterextends through a portion of the lock arrangement; an anchor configuredto be slidably carried on the inserter, wherein the inserter, driverassembly and anchor are arranged concentric about the longitudinal axiswhen assembled; and a distal tip configured to be removably coupled tothe distal end of the inserter, wherein the flexible member is disposedproximal of the distal tip when received in the eyelet, and wherein whenthe anchor is engaged with the distal tip and disposed in a pilot holein bone the flexible member is positioned entirely exterior of theanchor including around a distal end thereof and is positioned withinthe pilot hole.
 2. The system of claim 1, wherein the distal tip isconfigured to form the pilot hole in the bone via a force applied to thedriver assembly and the driver assembly is configured to insert theanchor into the pilot hole about the inserter and to engage the anchorwith the distal tip.
 3. The system of claim 1, wherein the anchor andflexible member are configured to be secured to the bone without forminga knot in the suture.
 4. The system of claim 1, wherein the eyelet isformed in the inserter between the proximal end and the distal endthereof.
 5. The system of claim 1, wherein the flexible member ispositioned entirely exterior of the anchor including around a distal endthereof and is positioned within the pilot hole when the anchor andflexible member are secured to the bone.
 6. The system of claim 1,wherein when the flexible member is received in the eyelet the flexiblemember extends through neither the distal tip nor the anchor, andwherein when the anchor and flexible member are secured to the bone theflexible member extends through neither the distal tip nor the anchor.7. The system of claim 1, wherein the lock arrangement is associatedwith the handle and includes a lock member selectively engageable withthe inserter in a first position of the plurality of positions in whichthe driver assembly is fixed to the inserter.
 8. The system of claim 7,wherein the driver assembly is rotatably and axially movable relative tothe inserter upon releasing the lock member from engagement at the firstposition.
 9. The system of claim 7, wherein the driver assembly isconfigured to be advanced relative to the inserter and is configured toinsert the anchor into the bone to a predetermined depth at which thelock member engages the inserter at a second position of the pluralityof positions axially spaced apart from the first position to fix thedriver assembly to the inserter.
 10. The system of claim 1, wherein theflexible member is disposed proximal of the distal tip when received inthe eyelet.